to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women

to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography

Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.

The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).

Drug: Korean red ginseng

Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.

Placebo Comparator: placebo

Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).

Drug: Placebo

Detailed Description:

Design

This trial is a randomized, double blind, placebo controlled trial with 80 patients.

The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea.

Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks.

During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.

Eligibility

Ages Eligible for Study:

16 Years to 60 Years (Child, Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female aged 16 to 60 years

Women complaining cold hypersensitivity on hands and feet

Thermal deviation between the palm and the upper arm is higher than 0.3℃

Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664156